Class II — ImaCor Inc.
| Recalling firm | ImaCor Inc |
|---|---|
| Registered facility | IMACOR, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes. |
| Product | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1 |
| Quantity | 73 units |
| Distribution | FL ,GA, NJ, TN |
| Initiated | 2024-09-16 |
| Classified | 2024-10-25 |
| Recall number | Z-0231-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ImaCor Inc. (Z-0231-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95459/
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